Jennifer Kaufman, DO,FACOFP David J Boes, DO, FACOOG MOA 12 TH ANNUAL AUTUMN SCIENTIFIC CONVENTION NOV. 5, 2016

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1 Caring for Common Problems in Post Menopausal Women Jennifer Kaufman, DO,FACOFP David J Boes, DO, FACOOG MOA 12 TH ANNUAL AUTUMN SCIENTIFIC CONVENTION NOV. 5, 2016

2 DISCLOSURES NONE RELATIVE TO THIS PRESENTATION

3 LEARNING OBJECTIVES After this session, the learner will be able to: Discuss the physiologic changes of menopause that lead to symptomatology Describe hormonal and non-hormonal treatments for vasomotor symptom-relief and genitourinary syndrome of menopause (Atrophic Vaginitis) Describe how the Women s Health Initiative and newer trials have shaped the viewpoint on hormone therapy Understand Bone loss and fracture risk after menopause and prevention/treatment strategies for bone health Understand how overall lifestyle modification and application of osteopathic principles can affect menopausal symptom-relief

4 5 major MENOPAUSAL issues 1. Vasomotor symptoms 2. Genitourinary syndrome (GSM/atrophic vaginitis) 3. Bone loss 4. Postmenopausal cardiovascular issues 5. Breast Cancer Risks 4

5 STAGES OF REPRODUCTIVE AGING STAGES: REPRODUCTIVE PERIOD MENOPAUSAL TRANSITION MENOPAUSE/POSTMENOPAUSE (PERIMENOPAUSE)

6 Estrogen Loss and Manifestations of Health Risks Over Time Short-term Symptoms Long-term Diseases Development of subclinical disease Estrogen Secretion Hot flushes Mood, sleep, and/or acute cognitive changes Urogenital symptoms Cardiovascular disease Osteoporosis Cognitive decline (Alzheimer s disease) Age (years)

7 What Peri/Postmenopausal women will present with: Irregular bleeding patterns Hot flashes Sleep disturbances Cognitive concerns (memory, concentration) Psychological symptoms (depression, anxiety, moodiness) Genitourinary symptoms Vaginal dryness Sexual dysfunction Miscellaneous Breast pain Menstrual migraines Skin changes Joint pain Balance issues There is no one universal menopausal syndrome

8 Case HF 52 year old caucasian female, G2 P 3012, presents with c/o Hot Flashes and Night sweats, with increasing severity over past 6 months. FDLMP : 9 months ago. Increased spacing between periods over past 2-3 years. Medical History: Tobacco, 25 pack year history. Quit: 1 year ago Etoh: 4-6 glasses wine /week Hyperlipidemia (controlled with Statin) PMH: no major problems Vitals: BMI : 30 BP: 134/88. Exam: normal

9 Case: management options? What would you offer her? What are options of management? How would you counsel her? Does she have any contraindications to HT?

10 (Case) Management OPTIONS LIFESTYLE MODIFICATIONS NON-PRESCRIPTION OTC products NONHORMONE prescription treatment HORMONE THERAPY (FDA Approved): [Transdermal, Transvaginal, Oral] HT (estrogen and progesterone/progestin) ET: (estrogen only) COMPOUNDED BIOIDENTICAL HT (NOT FDA Approved): SERM (ESTROGEN AGONIST/ANTAGONIST)

11 VASOMOTOR SYMPTOMS Anatomy of a hot flash PHYSIOLOGIC CHANGES The hot flush Mechanism not fully understood Decreased estrogen level, increased FSH Narrowed thermoregulatory zone of core body temperature CENTRAL NERVOUS SYSTEM: Serotonergic, noradrenergic, opioid, adrenal and autonomic systems also involved Ethnic/genetic differences

12 MENOPAUSAL HOT FLASHES MOST COMMON SYMPTOM FOR WHICH MENOPAUSAL WOMEN SEEK TREATMENT BRAIN RELATED PHENOMENON, SO CENTRALLY ACTING TREATMENT REQUIRED MEDIAN DURATION OF HF > 10 YEARS HF INCREASED WITH : INCREASED BMI, INDUCED MENOPAUSE, BLACK RACE, SMOKING, MOOD DISORDERS

13 GOLD STANDARD FOR HOT FLASHES ESTROGEN REVIEW CURRENT EVIDENCE ALTERNATIVES?? COMPARE EFFICACY CONTROVERSIES?? Therapeutic Goals Maintain quality of life Treat the most bothersome symptoms for the patient Individualize therapy based on patient s medical history, risk factors and desire for type of treatment HOW DOES THIS DIFFER FROM 1995?, 2003?

14 Do we recommend or not? Hormone Therapy

15 Hormone Therapy WHAT ARE THE BENEFITS?? WHAT ARE THE RISKS?? WHAT ARE THE QUALITY OF LIFE ISSUES???

16 Hormone Therapy 3 Major Benefits: Relieve vasomotor symptoms Alleviate vulvar/vaginal atrophy May have an effect on sexual function Reduction in postmenopausal osteoporotic fractures Potential Risks We will discuss Coronary heart disease (???) Breast cancer:(ept, ET)? Stroke VTE/Pulmonary embolism Endometrial cancer (ET)

17 Back to our patient What would you offer her?? I ve heard about WHI a thousand times! What about the WHI??

18 What happened on a HOT SUMMER night in 2002?? WHI E-P ARM: discontinued due to reported risks and released to media before published or notification to physicians CEE/MPA RX

19 WHI IN

20 Hormone therapy: Women s Health Initiative Large RCT to determine if hormones prevent heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women Enrolled women ages (average age 63) One arm of trial (11,000 women) continuous, combined E-P vs placebo Other arm (16,000 women) estrogen only Was scheduled to be completed in 2005, but both arms terminated early Prescriptions for HT decreased by approx. 38% in the first year post-whi

21 90% > age 60 Initial data, non abjudicated

22 WHI: Limitations and Criticisms Older population (mean age 63) Heavier women (BMI>30) 50% pts were current or past smokers Only one route of administration Only one formulation of estrogen and progestogen (HIGHER DOSE CEE,.625MG &MPA, 2.5MG) Should not be extrapolated to pts with premature ovarian failure OR premenopausal oophorectomy High crossover (from intention to treat), & dropout rates

23 WHI: Limitations and Criticisms Conclusions--- were not stratified by age/decade or time since menopause Reanalysis of data suggests that HT/ET in younger postmenopausal women may not be as detrimental, and in fact, benefits > risks Many experts called for studies to evaluate hormone therapy in newly menopausal women Large observational studies (such as Nurses Health Study) did not corroborate some of WHI findings

24 REEVALUATING WHI Where do we stand in 2016? In 2012, NAMS, ASRM, Endocrine Society prepared a statement summarizing WHI and expert recommendations : Systemic hormone therapy is an acceptable option for relatively young and healthy women who are bothered by moderate to severe menopausal symptoms. Women up to age 59 or within 10 years of menopause (greatest benefit, minimal risk) Consider her quality-of-life priorities and risk factors: age, time since menopause, risk of VTE, stroke, and breast cancer Counsel and Individualize treatment

25 REEVALUATING WHI Where do we stand in 2016? Estrogen plus progestogen therapy in women with a uterus to prevent endometrial hyperplasia/cancer Local estrogen therapy for women with vaginal dryness, discomfort with intercourse Lowest dose of hormone for the shortest amount of time to manage menopausal symptoms Risk of VTE is increased with E+P or E alone, but the risk is rare in women ages may be less in transdermal vs oral Risk of breast cancer increased with 5 years or more with continuous E+P (not with E alone in WHI)

26 Hormone therapy: Where do we stand now? KEEPS trial (Kronos Early Estrogen Prevention Study) {2012} Four-year double-blinded placebo-controlled trial Excluded women with: Evidence of cardiovascular disease (including coronary artery calcium scores of 50 or higher) Cholesterol/triglyceride levels requiring lipid-lowering agents Severe obesity Heavy smoking Over 700 women in three arms (ages 42-59) 1) Oral conjugated equine estrogen, 0.45 mg/day 2) Transdermal estradiol patch, 0.05 mg/day 3) Placebo Oral Micronized progesterone 200 mg for 12 days each month

27 Hormone Therapy [EPT]: KEEPS trial CONCLUSIONS: EPT started soon after Menopause---SAFE/REASSURANCE Decreased symptoms of menopause [HF, Night Sweats] Improved Sexual Function Improved vaginal lubrication Decreased pain with intercourse Increased bone mineral density Improved Mood Improves several markers of CV risk

28 Hormone therapy: KEEPS trial Assessment of atherosclerosis prevention Carotid artery intima-media thickness assessed by yearly carotid ultrasound imaging Similar rates of progression in all three treatment groups Assessment of coronary artery calcium scores via high-resolution CT scans before and at the end of the study Very little progression in CAC scores overall Mild increase in women with established CAC Trend toward less progression in both HT groups

29 Hormone therapy: KEEPS trial Other FINDINGS: BP: No increase in systolic or diastolic BP LIPIDS & GLUCOSE METABOLISM Oral CEE group with increased HDL, decreased LDL Transdermal E2 with improved glucose levels, insulin sensitivity CANCER AND CVD No statistically significant change in breast or endometrial cancer, MI, stroke/tia, VTE Cognition: No significant beneficial or adverse effects overall Oral CEE had improvements in depressive symptoms, anxiety/tension, and mood

30 Hormone Therapy 2016 Safe to use in newly menopausal women up to age 59 and within 10 years of menopause Weigh risks/benefits age 60-69, (ok to continue if benefits > risks) Lowest effective dose for the shortest amount of time Low-dose and ultra-low systemic doses of estrogen assoc with better adverse effect profile Counsel regarding all options Weigh overall risks and benefits

31 WHI-----effects of In 13 years since publication of WHI, use of HT has decreased markedly worldwide, and prevalence of use has remained low. WHI has resulted in millions of women receiving no treatment and consequently experiencing reduced quality of life WHI results inappropriately led to d/c HT in all age groups (re: younger women etc)

32 HORMONE THERAPY GREATEST RISK: DVT/PE GREATEST PERCEIVED RISK: BREAST CANCER WHI EP THERAPY: < 1/1000 added RISK, BUT PRESENT ET THERAPY: REDUCED RISK PER WHI NO LONG TERM DATA BEYOND WHI

33 Timing Hypothesis What is it?

34 HORMONE THERAPY TIMING HYPOTHESIS: TIMING OF INITIATION OF HT IMPORTANT EARLY: PROTECTIVE LATE: INCREASED RISK OF CV MORBIDITY HT MAY INCREASE RISK FOR CAD WHEN INITIATED LATER IN LIFE, AFTER PLAQUE ALREADY PRESENT IN CORONARY ARTERIES YOUNGER AGE, CARDIOPROTECTIVE (AGE 50-59)

35 What about these products? Do they work?

36 HF: NON PRESCRIPTION TREATMENT OTC Isoflavones, red clover, soy, black cohosh, Chinese herbs NO BETTER THAN PLACEBO PLACEBO EFFECT: UP TO 30% for BRAIN/CNS Rx. In women who benefit from placebo effect, nonharmful tx need not be discouraged OTC should not be prescribed if patient requires definitive tx

37 NONHORMONE PRESCRIPTION TX Less effective than HT, but > placebo SSRI & SNRI PAROXETINE 7.5 mg. (approved) Side effects: sexual (libido), fatigue, dizziness, nausea SSRI : should not be used in Breast CA pt. on Tamoxifen Gabapentin Side effects: fatigue (may be better at HS)

38 COMPOUNDED BIOIDENTICAL HT Used by 2.5 million women Big $$ $ in compounding, salivary testing etc. Compounding not FDA regulated, lack of consistency & risks/benefits same There are FDA approved Bioidentical hormones (Estradiol) and Progesterone(micronized) FDA, NAMS, ACOG do not recommend

39 SERM PLUS CEE CEE/Bazedoxifene (BZA) [.45/20 mg] Appropriate in pt with uterus & concerns about breast cancer/breast density No increase in breast density/ don t know yet if decreases breast ca

40 FORMS OF ET, EPT TRANSDERMAL: ORAL Observational data (Europe) suggests lower risk of VTE/PE Avoids 1 st pass through liver = decrease thrombogenic effect Especially consider in high risk groups such as obesity, and age > 60 CEE (most widely studied), Estradiol (E-2) may be lower risk for thrombosis.

41

42

43 True or False? Smoking (tobacco) is a contraindication to the use of menopausal hormone therapy.

44 Hormone Therapy: Contraindications Presence of breast or endometrial cancer Active thrombophlebitis Undiagnosed vaginal bleeding Known or suspected pregnancy Relative contraindications include: history of breast/endometrial CA, history of VTE, liver ds

45

46 Case # 2 A 63 year old female comes to your office with chief complaint of dyspareunia. She has been divorced and recently become sexually active again in a new relationship after 10 years of abstinence. She also reports vaginal dryness and occasional pruritus. On physical exam, she has significant discomfort with the bimanual exam and you note pale pink, thin vaginal epithelium.

47 Vulvovaginal Atrophy A.k.a. genitourinary syndrome of menopause Typically occurs in 10-40% of older women Progressive and less likely to resolve without intervention Has a significant impact on a woman s sexual health and quality of life. REVIVE, largest survey of US women (0ver 3,000 participants), found that only 7% of women with VVA reported their symptoms to their physician NAMS pos statement p 889

48 The Physiologic Changes: Genitourinary Syndrome of Menopause Structural Reduced collagen content, elastin, hyalinization Thinning of epithelium Altered appearance and function of smooth muscle cells Increased density of connective tissue Decreased blood supply Increase in immature parabasal cells, decrease in superficial cells Decreased glycogen levels and subsequent increase in vaginal ph

49 The Physiologic Changes: Genitourinary Syndrome of Menopause Physiologic Reduced blood flow Decreased lubrication Decreased flexibility/elasticity of vaginal vault Increased vaginal ph

50 Artist s rendering of atrophic vulvar changes Google images

51

52 Hypoestrogenic state Loss of vaginal rugae and elasticity with narrowing and shortening of the vagina Epithelial tissues are more fragile and may tear leading to bleeding and fissures Loss of subcutaneous fat in the labia majora, resulting in narrowing of the introitus, fusion of the labia minora and shrinking of the clitoral prepuce and urethra. Vaginal ph becomes more alkaline, which may alter the vaginal flora and increase the risk of urogenital infections Vaginal secretions decrease All of the changes lead to significant dyspareunia, which can impair sexual function as well as dryness, burning, pruritus, discharge, bleeding, spotting, urinary frequency and recurrent bladder infections ACOG Prac Bull

53 Non-hormonal Treatments Vaginal moisturizers- applied a few times weekly Replens, Me Again, Vagisil, Feminine Moist, Feminease, K-Y Silk-E Vaginal lubricants-applied prior to intercourse Water-soluble- Astroglide, Slippery Stuff, K-Y jelly Silicone-based- Pjur Eros, ID Millinium Oil-based- Elegance Sexual activity Use it or lose it. Vaginal dilators UTD, others Set of graduated sizes, instructions on use taught by physician or pelvic PT. Consider topical estrogen prior to use

54 Estrogen therapy Most effective for moderate to severe VVA Restoration of normally acidic vaginal ph and microflora, thickening of the epithelium, increased vaginal secretions and decreased vaginal dryness. Reduction of OAB symptoms. Not indicated for stress or urge incontinence as prior studies have not shown benefit with use. Contraindications- caution in women with or at increased risk for estrogen-dependent tumors. Controversial in women with breast cancer

55 Low-dose Vaginal Estrogen Therapy Defined as concentrations less than 50 mcg or 0.3 mg conjungated estrogens Typically have similar estradiol levels as those not taking exogenous estrogen, however, systemic effects are possible but not likely Dose and duration may vary. Trials have not followed women treated with vaginal estrogen beyond a year Vaginal estrogen treatments Vagifem- 10 mcg tab, insert daily for 2 weeks, then twice weekly thereafter Estring- 7.5 mcg silastic ring inserted vaginally, for 90 days Premarin- 0.3 mg/0.5 g cream- considered low dose at this concentration

56 High-dose estrogen therapy Femring mcg- considered systemic and also indicated for treatment of vasomotor symptoms Conjugated estrogens- Premarin mg/1 g cream Cyclic regimen: daily for 21 days and off for 7 days Continuous: daily for 1-2 weeks, then twice weekly Estrace- 100 mcg/1 g cream- 2-4 g daily for 1-2 weeks, then gradually reduce to half the initial dose for a similar period. Maintenance dose of 1 g, 1-3 times weekly

57 Serum estrogen levels with local treatments Premenopausal women Serum estrogen level pg/ml < 30 pg/ml Postmenopausal women Estrogen Serum concentration Vagifem 10 mcg tab 3-11 pg/ml Estring 7.5 mcg ring 5-10 pg/ml Premarin mg cream Estrace 100 mcg cream Unknown, as there are > 200 compounds, come estrogenic and others antiestrogenic. Serum concentration does not correlate with activity level 40 pg/ml

58 Risks of Estrogen Therapy Higher serum estrogen concentrations lower serum gonadotropic concentrations and may induce endometrial proliferation. Progestins are recommended as adjunct therapy with any high dose estrogen treatments. Progestins are given for consecutive days per month Progestins Medroxyprogesterone 10 mg Norethindrone acetate 5-10 mg Micronized progestertone 200 g

59 Estrogen Agonist and Antagonists Selective estrogen receptor modulators Ospemifene (Osphena)- FDA approval for treatment of moderate to severe dyspareunia Estrogen agonist in the vagina, without clinically significant estrogenic effect on the endometrium or breast. Recommended for women who cannot or prefer not to use a vaginal product Disadvantages (compared to vaginal estrogen) include need for daily use and systemic side-effects such as hot flashes and potential risk of thromboembolism. Safety of Osphena has not been demonstrated in women with a prior history of or increased risk of breast cancer or in women with increased risk of VTE. Causes reduction in bone turnover Raloxifen and Tamoxifen are not FDA approved for treatment of dyspareunia

60 Case # 2 A 43 year old female patient who was recently treated for breast cancer has history of dyspareunia. She is currently taking tamoxifen. She is wondering what treatment options are available for her.

61 VVA in Women with Breast Cancer VVA symptoms are a common complaint in women with breast cancer, particularly those on endocrine treatments (aromatase inhibitors or tamoxifen). First line treatment is non-hormonal Few data regarding safety of vaginal estrogen therapy are available. Estrogen therapy should NOT be used in women using aromatase inhibitor therapy for breast cancer It is reasonable to prescribe low-dose vaginal estrogen in women taking tamoxifen only after discussion with her oncologist. Vaginal testosterone is under investigation and has not been shown to increase serum estrogen. It s efficacy is questionable

62

63 Cases---- it depends questions?? Breast Ca risk or history No HT or ET in women with breast Ca Hx of DVT (non traumatic) No HT or ET Patient with oophorectomy before age 50 because of ovarian pathology. Risk factors: tobacco, obesity Low dose, transdermal may be safest

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